Postoperative Alpha Lipoic Acid in the Carpal Tunnel Syndrome: a Randomized Controlled Trial.

The Association of Alpha Lipoic Acid to the Median Nerve Decompression in the Carpal Tunnel Syndrome: a Randomized Controlled Trial.

The postoperative course of the decompression of the median nerve in the carpal tunnel syndrome can sometimes be complicated by pain, paresthesias and other unpleasant symptoms, or may be characterized by a slow recovery of nerve function. Lipoic acid is considered to be a powerful and effective antioxidant with neuroprotective and neurotrophic properties. Dietary supplementation with lipoic acid helps reduce the damage to the nervous structure. Its action as a dietary supplement may positively modulate and accelerate healing after decompression of the median nerve.

The aim of the study is to explore any possible effects of this molecule in the postoperative period after decompression of the median nerve at the wrist.

Patients will be enrolled with proven carpal tunnel syndrome. By means of randomization, patients will be placed into one of two groups:

Group A: surgical decompression of the median nerve followed by alpha lipoic acid, 800 mg daily for 40 days.

Group B: surgical decompression of the median nerve followed by treatment with placebo

The primary endpoint of the study will be Nerve conduction velocity at 3 months after surgery after 50 days of discontinuing treatment with alpha lipoic acid (TIOBEC) / PLACEBO.

Study Overview

• Status: Completed
• Conditions: Entrapment Neuropathy, Carpal Tunnel; Compression Neuropathy, Carpal Tunnel; Median Neuropathy, Carpal Tunnel
• Intervention / Treatment: Procedure: Median nerve decompression at the wrist; Dietary supplement: Alpha lipoic acid post median nerve decompression

Detailed Description

The postoperative course of the decompression of the median nerve in the carpal tunnel syndrome can sometimes be complicated by pain, paresthesias and other unpleasant symptoms, or may be characterized by a slow recovery of nerve function, often also because of a prolonged illness prior to the decompression, causing extensive damage to the nerve, including demyelination, or other morphofunctional deficits. For this reason it could be particularly useful to associate a dietary supplement as a support to the structure and physiology of nerve in the post-decompression period. In this respect, the alpha-lipoic acid molecule seems to be a particularly interesting. Lipoic acid is considered to be a powerful and effective antioxidant with neuroprotective and neurotrophic properties. Dietary supplementation with lipoic acid helps reduce the damage to the nervous structure. Its action as a dietary supplement may positively modulate and accelerate healing after decompression of the median nerve.

The aim of the study is to explore any possible effects of this molecule in the postoperative period after decompression of the median nerve at the wrist.

Patients will be enrolled with proven carpal tunnel syndrome, confirmed by a careful examination including the diagnostic maneuvers Phalen, Tinel and antiPhalen. By means of randomization, patients will be placed into one of two groups:

Group A: surgical decompression of the median nerve followed by alpha lipoic acid, 800 mg daily for 40 days.

Group B: surgical decompression of the median nerve followed by treatment with placebo Surgical treatment is performed in both groups according to the standard for this type of intervention, and within 90 days after joining the waiting list.

Patients will be excluded in case of recurrent carpal tunnel syndrome. Other causes of exclusion will be carpal tunnel syndrome associated with diabetes mellitus or rheumatoid hand or secondary to other causes, uncooperative patients with poor compliance with treatment, patients with hypersensitivity to the product or one of its components, patients with pace-maker as this does not allow nerve conduction studies and electromyography, needed to evaluate pre and post treatment.

The primary endpoint of the study will be Nerve conduction velocity at 3 months after surgery after 50 days of discontinuing treatment with alpha lipoic acid (TIOBEC) / PLACEBO.

Secondary endpoints:

1. assessment of pain reported by the patient using the VAS (Visual Analogue Scale).
2. Clinical evaluation objective (presence of paresthesia and two-point discrimination on the tip of the index finger, and subjective (symptom description by the patient by means of tests and Levine-Katz questionnaire) at 3 and 6 months.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Istituto Ortopedico Rizzoli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients suffering from primary carpal tunnel syndrome, confirmed clinically and with nerve conduction studies

Exclusion Criteria:

• Recurrent or secondary carpal tunnel syndromes.
• Diabetic patients.
• Patients with pace-makers.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lipoic; Median nerve decompression at the wrist, followed by Alpha lipoic acid post median nerve decompression: lipoic acid, 800 mg daily for 40 days from the day of the operation, tablets.	Procedure: Median nerve decompression at the wrist; Surgical incision of the carpal ligament at the wrist and proximal hand to decompress the median nerve.; Dietary supplement: Alpha lipoic acid post median nerve decompression; Daily supplementation of alpha lipoic acid
Placebo Comparator: placebo; Median nerve decompression at the wrist, followed by placebo in the same form frequency and duration as alpha lipoic acid	Procedure: Median nerve decompression at the wrist; Surgical incision of the carpal ligament at the wrist and proximal hand to decompress the median nerve.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Median nerve conduction velocity	Preoperatively and 90 days after median nerve decompression

Secondary Outcome Measures

Outcome Measure	Time Frame
Score with Boston questionnaire on carpal tunnel syndrome	Preoperatively and 90 days postdecompression
Two point discrimination test on index finger pulp	Preoperatively and 90 days postdecompression

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli
• Investigators: Principal Investigator: Filippo Boriani, MD, Istituto Ortopedico Rizzoli

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: June 25, 2013
• First Submitted That Met QC Criteria: July 5, 2013
• First Posted (Estimate): July 10, 2013

Study Record Updates

• Last Update Posted (Estimate): June 24, 2015
• Last Update Submitted That Met QC Criteria: June 23, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Congenital Abnormalities; Genetic Diseases, Inborn; Neuromuscular Diseases; Neurodegenerative Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Cumulative Trauma Disorders; Sprains and Strains; Heredodegenerative Disorders, Nervous System; Nervous System Malformations; Polyneuropathies; Carpal Tunnel Syndrome; Nerve Compression Syndromes; Charcot-Marie-Tooth Disease; Hereditary Sensory and Motor Neuropathy; Median Neuropathy; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Vitamin B Complex; Thioctic Acid
• Other Study ID Numbers: TUNNEL ALFALIPO